| Trial ID: | L4596 |
| Source ID: | NCT00571519
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| Associated Drug: |
Rivoglitazone Hcl
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| Title: |
Randomized, Double-blind, Active-controlled, Study of Rivoglitazone in Type 2 Diabetes Mellitus
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| Acronym: |
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| Status: |
TERMINATED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT00571519/results
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| Conditions: |
Type 2 Diabetes Mellitus
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| Interventions: |
DRUG: Rivoglitazone HCl|DRUG: rivoglitazone HCl|DRUG: rivoglitazone HCl|DRUG: placebo|DRUG: pioglitazone HCl|DRUG: pioglitazone HCl|DRUG: pioglitazone HCl 45 mg|DRUG: placebo|DRUG: metformin
|
| Outcome Measures: |
Primary: Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus, Glycosylated hemoglobin (A1c) levels and mean changes in A1c were used to measure glycemic control. A1c categorical targets are \<7.0% and \<6.5%., Baseline up to week 2, week 4, week 6, week 8, week 10, week 12, week 16, and week 20 post-dose. | Secondary: Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus, Normal fasting plasma glucose (FPG) -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline and a lower FPG means improvement., Baseline up to week 2, week 4, week 6, week 8, week 12, week 16, and week 20 post-dose.|Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus, Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol., Baseline up to week 12 post-dose.|Percent Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus, Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol., Baseline up to week 12 post-dose.|Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus, Total Triglycerides (TG) is a measure of the total amount of triglycerides in the blood. The equation to calculate total triglycerides is: (total cholesterol-Low-density Lipoprotein cholesterol (LDL- C) - High-density lipoprotein cholesterol (HDL- C)) x 5 = Total Triglycerides. A negative change means improvement., Baseline up to week 12 post-dose.|Percent Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus, Total Triglycerides (TG) is a measure of the total amount of triglycerides in the blood. The equation to calculate total triglycerides is: (total cholesterol-Low-density Lipoprotein cholesterol (LDL- C) - High-density lipoprotein cholesterol (HDL- C)) x 5 = Total Triglycerides. A negative change means improvement., Baseline up to week 12 post-dose.|Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus, Low-density lipoprotein cholesterol (LDL-C) is a measure of the total amount of low-density lipoprotein cholesterol in the blood. LDL-C was measured as part of the fasting lipid panel. LDL-C is considered "bad" cholesterol, so a lower score (negative change) means improvement., Baseline up to week 12 post-dose.|Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus, Low-density lipoprotein cholesterol (LDL-C) is a measure of the total amount of low-density lipoprotein cholesterol in the blood. LDL-C was measured as part of the fasting lipid panel. LDL-C is considered "bad" cholesterol, so a lower score (negative change) means improvement., Baseline up to week 12 post-dose.|Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus, High-density lipoprotein cholesterol (HDL-C) is a measure of the total amount of high-density lipoprotein cholesterol in the blood. HDL-C was measured as part of the fasting lipid panel. HDL-C is considered "good" cholesterol, so a higher score (positive change) means improvement., Baseline up to week 12 post-dose.|Percent Change in High-Density Lipoprotein Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus, High-density lipoprotein cholesterol (HDL-C) is a measure of the total amount of high-density lipoprotein cholesterol in the blood. HDL-C was measured as part of the fasting lipid panel. HDL-C is considered "good" cholesterol, so a higher score (positive change) means improvement., Baseline up to week 12 post-dose.|Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus, Apolipoprotein (Apo) A-I is a measure of the total amount of Apolipoprotein (Apo) A-I in the blood. Apo A-I was measured as part of the fasting lipid panel., Baseline up to week 12 post-dose.|Percent Change in Apolipoprotein (Apo) A-I From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus, Apolipoprotein (Apo) A-I is a measure of the total amount of Apolipoprotein (Apo) A-I in the blood. Apo A-I was measured as part of the fasting lipid panel., Baseline up to week 12 post-dose.|Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus, Apolipoprotein (Apo) B is a measure of the total amount of Apolipoprotein (Apo) B in the blood. Apo B was measured as part of the fasting lipid panel., Baseline up to week 12 post-dose.|Percent Change in Apolipoprotein (Apo) B From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus, Apolipoprotein (Apo) B is a measure of the total amount of Apolipoprotein (Apo) B in the blood. Apo B was measured as part of the fasting lipid panel., Baseline up to week 12 post-dose.|Number of Participants With Treatment-Emergent Adverse Events by System Organ Class and Preferred Term Following Rivoglitazone or Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus, Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of randomized study medication and ongoing adverse events that started prior to the first dose of randomized study medication and increased in severity on or after the first dose of randomized study medication., Baseline up to week 26 post-dose, approximately a total of 27 weeks.
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| Sponsor/Collaborators: |
Sponsor: Daiichi Sankyo
|
| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
|
| Enrollment: |
94
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
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| Start Date: |
2007-11-14
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| Completion Date: |
2008-05-23
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| Results First Posted: |
2021-02-26
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| Last Update Posted: |
2021-05-26
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| Locations: |
Huntsville, Alabama, 35801, United States|Huntsville, Alabama, 35802, United States|San Diego, California, 92128, United States|San Francisco, California, 94115, United States|Ridgefield, Connecticut, 06877, United States|Fort Lauderdale, Florida, 33308, United States|Pembroke Pines, Florida, 33026, United States|Port Gibson, Mississippi, 39150, United States|Las Vegas, Nevada, 89119, United States|Albuquerque, New Mexico, 87109, United States|Kettering, Ohio, 45429, United States|Fleetwood, Pennsylvania, 19522, United States|Harrisburg, Pennsylvania, 17112, United States|Simpsonville, South Carolina, 29681, United States|Daingerfield, Texas, 75638, United States|Dallas, Texas, 75216, United States|Plano, Texas, 75093, United States|San Antonio, Texas, 78205, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00571519
|
